340B Providers Might Benefit From Closing of Medicaid Rebate "Loophole" March 30, 2010 - The health care reform package that President Obama signed today contains a little-noticed Medicaid drug rebate provision that could add up to significant savings for 340B providers and the Medicaid program. Backgrounder: Additional Medicaid Rebate for Brand-Name … [Read more...]
340B Providers Cannot Sue for Overcharges, U.S. Supreme Court Rules
Focus shifts to formal dispute resolution system that is still on the drawing board.March 29, 2011— The U.S. Supreme Court ruled today that 340B providers do not have a right to sue drug manufacturers for overcharges as the beneficiaries of pricing agreements between the companies and the federal government. The unanimous decision effectively ends a landmark case brought by two California countiesagainst nine major drug manufacturers alleging that they were … [Read more...]
Impasse Continues Over Federal 2011 Spending
Government shutdown looms.March 28, 2011—Congress has returned to work after a weeklong recess with the clock winding down on its latest stop-gap spending bill to keep federal agencies open. The current continuing resolution expires on April 8. If the Democratic-led Senate and the Republican-led House cannot come to an agreement the government will be forced to close, including the Office of Pharmacy … [Read more...]
Brand-Name Drug Prices Rising Sharply, Studies Find
340B inflation adjustment offers providers some relief.March 28, 2011—Four new studies—by an investment bank, a research firm, a health insurer and a congressional agency—conclude that brand-name drug prices have been outpacing inflation by a wide margin while generic drugs prices have been either falling or holding steady. U.S. House Democrats who commissioned one of the reports say the findings warrant a congressional … [Read more...]
Biogen Idec and Santarus to Provide 340B Refunds
Affected products include Biogen's blockbuster drug for multiple sclerosis.March 16, 2011—The manufacturer of Avonex, a leading treatment for relapsing-remitting multiple sclerosis (MS), has informed the Office of Pharmacy Affairs (OPA) that it will be repaying 340B covered entities for overcharges on the biotech drug during the fourth quarter of 2000 through the first quarter of 2008. The company, Biogen Idec, also told OPA that it was sending … [Read more...]
Record Number of Orphan Drugs Are Under Development
Growth points to manufacturers' embrace of sector as a moneymaker.March 8, 2011—A record 460 orphan drugs are in late-stage development in the United States, either in clinical trials or awaiting Food and Drug Administration (FDA) review, according to a new report by Pharmaceutical Research and Manufacturers of America (PhRMA). That's a roughly 50 percent increase above the number under development in 2007 and about three and a half times … [Read more...]
Staff Departures Are Compounding OPA’s Budget Problem
Four open positions can't be filled due to hiring freeze.March 8, 2011—The Office of Pharmacy Affairs (OPA) is down three staff members from its all-time high of 19 in December and is losing a fourth at the end of this week. The departures reportedly are hitting the office hard, as it is under an informal hiring freeze given ongoing uncertainty about its budget. OPA's spending for the current fiscal will run out on March 18 and it … [Read more...]